SeeMedX has submitted its 510(k) premarket notification to the US Food and Drug Administration (FDA) for a non-invasive cardiac monitoring device.
The technology provides real-time insights into heart performance and fluid status, helping medical professionals make faster, more informed decisions.
The cardiac monitoring device is designed to improve heart failure treatment, offering enhanced speed and safety compared to current options.
SeeMedX’s non-invasive device offers precise haemodynamic measurements, including Zo (fluid status) and CO (cardiac output).
The technology allows clinicians to detect volume overload and other heart failure symptoms earlier than traditional methods, leading to improved patient outcomes.
The device delivers real-time insights into key indicators, helping clinicians make timely decisions for optimised heart failure treatment.
Its non-invasive nature ensures a painless experience for patients, enhancing both comfort and clinical efficiency. Additionally, SeeMedX’s solution streamlines hospital workflows by facilitating faster interventions and supporting timely, data-driven clinical decisions.
SeeMedX CEO Deborah Simpson said: “This submission marks a major milestone for SeeMedX in advancing heart failure care.
“After the unexpected loss of my father, I made it my personal mission to develop a life-changing solution for heart failure treatment.
“Our goal is to empower clinicians with tools that ultimately improve outcomes for patients everywhere.”
Pending FDA clearance, SeeMedX is preparing for the US commercial launch of its cardiac monitoring device.
The company also plans to pursue regulatory approvals in additional global markets to expand access to its technology.
SeeMedX aims to improve lives by providing non-invasive monitoring solutions that empower healthcare professionals with fast, painless, and intuitive real-time data.
Its technologies are designed for assessing cardiac performance and fluid status, helping clinicians make informed, timely decisions to optimise heart failure treatment and enhance patient outcomes.
